MalocclusionNCT06873932
Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners
A study testing Arm 1: Beveled Attachments and Conventional Rectangular Attachments in people with Malocclusion and Tooth Movement Techniques, run by Neodent at 1 site in Brazil.
Trial summary
The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Tooth Movement Techniques
- What is being tested?
- Arm 1: Beveled Attachments and Conventional Rectangular Attachments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Oct 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18+ years) with permanent dentition
- Candidates for aligner-based orthodontic treatment
- Require bilateral tooth movements (e.g., extrusion, intrusion, rotation, tipping, mesiodistal translation)
- Provide written informed consent
Who cannot join
- Contraindications to aligner use (e.g., manufacturer's guidelines)
- Poor oral hygiene, active periodontal disease, or TMJ disorders
- Allergies to aligner materials (e.g., polyurethane, PETG)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to July 2027). Participants will be selected and randomized using a split-mouth study design. Groups will be divided into rectangular and beveled attachments, each further subdivided into subgroups for horizontal movements (Group H), vertical movements (Group V), and rotations (Group R), with 20 teeth/attachments per group, totaling a sample of 120 teeth/attachments. Digital study models will be obtained before the start of treatment and immediately after its completion. Additionally, clinical intraoral and extraoral photographs will be taken (pre- and post-treatment). Measurements will be collected from the initial and final digital models to determine the magnitude and direction of movements resulting from treatment. Descriptive statistics will be calculated for each type of dental movement evaluated. Paired tests will be conducted due to the split-mouth design. Correlation tests will be applied if necessary.
Read the detailed description
Participant recruitment will take place after approval by the Research Ethics Committee until July 2027. The consultations will occur in a private clinic in Curitiba - PR, Brazil.
Participants will be selected and randomized according to the split-mouth study design. Teeth on each side will have different attachment configurations to aid orthodontic aligner movements. One side will use rectangular attachments, and the other side will use beveled attachments. Groups will be divided as follows:
Group H: 20 teeth/attachments with horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Group V: 20 teeth/attachments with vertical displacements (extrusion and intrusion) - incisors.
Group R: 20 teeth/attachments with mesio-distal rotations - canines and premolars.
Digital study models (intraoral scanner) will be obtained before and after treatment. These intraoral scans will be analyzed alongside the planned movement models generated by the orthodontic treatment planning software.
Treatment efficacy will be analyzed using tooth-tracking methodology in Geomagic Control X, measuring the differences between planned and achieved movements and calculating the percentage of achieved orthodontic tooth movement.
Additionally, pre- and post-treatment clinical photographs will be taken:
Intraoral:
Frontal in occlusion; Right and left lateral views in occlusion; Occlusal views of upper and lower arches.
Extraoral:
Frontal with lips at rest; Frontal with a wide smile; Profile with lips at rest. All participants will receive orthodontic aligner treatment supervised by a qualified professional capable of providing relevant care under clinical trial conditions. Diagnosis, movement planning, and therapy monitoring procedures (e.g., aligner replacement frequency) for each individual will be established by the researcher, respecting the manufacturer's specified instructions.
The sample size was 30 participants will be recruited, totaling a sample of 120 teeth/attachments.
Participant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.
Initial and final digital models will be imported using software, where measurements will be taken to identify the magnitude and direction of movements resulting from treatment with different attachment types:
Horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Vertical displacements (extrusion and intrusion) - incisors. Mesio-distal rotations - canines and premolars.
Descriptive statistics will be calculated for each type of tooth movement evaluated and described by mean, standard deviation, median, quartiles, minimum, and maximum. Paired tests will be conducted due to the split-mouth design. Correlation tests will also be applied if necessary.
- Conditions
- Malocclusion, Tooth Movement Techniques
- Being tested
- Arm 1: Beveled Attachments, Conventional Rectangular Attachments
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Beveled AttachmentsDevice
Beveled attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).
Conventional Rectangular AttachmentsDevice
Conventional rectangular attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).
| Study group | Role | What they receive |
|---|---|---|
| Arm: Beveled attachments | Experimental | The patients will receive beveled attachments on one side of the jaws Receives: Device: Arm 1: Beveled Attachments |
| Rectangular Attachments | Active comparator | The patients will receive rectangular attachments on one side of the jaws Receives: Device: Conventional Rectangular Attachments |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of dental movement using beveled and conventional attachments
Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.
Measured: From enrollment to the end of treatment, not exceeding 24 months.
Secondary outcomes (3)
To measure dental movements achieved with the treatment.
To measure the horizontal, vertical, and rotational dental movements achieved with the treatment
Measured: From enrollment to the end of treatment, not exceeding 24 months.
Measure the transverse dental changes achieved.
Transverse dental changes will be analyzed by comparing pre-treatment and post-treatment digital dental scans.
Measured: From enrollment to the end of treatment, not exceeding 24 months.
To assess participant satisfaction throughout the treatment.
Participant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.
Measured: From enrollment to the end of treatment, not exceeding 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start25 Oct 2024
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neodent
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873932
- Sponsor's protocol ID
- CC.2024.Attachments
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT06873932
- Acronym / sponsor ID
- CC.2024.Attachments
- Conditions
- Malocclusion, Tooth Movement Techniques
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- NeodentIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to July 2027). Participants will be selected and randomized using a split-mouth study design. Groups will be divided into rectangular and beveled attachments, each further subdivided into subgroups for horizontal movements (Group H), vertical movements (Group V), and rotations (Group R), with 20 teeth/attachments per group, totaling a sample of 120 teeth/attachments. Digital study models will be obtained before the start of treatment and immediately after its completion. Additionally, clinical intraoral and extraoral photographs will be taken (pre- and post-treatment). Measurements will be collected from the initial and final digital models to determine the magnitude and direction of movements resulting from treatment. Descriptive statistics will be calculated for each type of dental movement evaluated. Paired tests will be conducted due to the split-mouth design. Correlation tests will be applied if necessary.
Detailed description
Participant recruitment will take place after approval by the Research Ethics Committee until July 2027. The consultations will occur in a private clinic in Curitiba - PR, Brazil.
Participants will be selected and randomized according to the split-mouth study design. Teeth on each side will have different attachment configurations to aid orthodontic aligner movements. One side will use rectangular attachments, and the other side will use beveled attachments. Groups will be divided as follows:
Group H: 20 teeth/attachments with horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Group V: 20 teeth/attachments with vertical displacements (extrusion and intrusion) - incisors.
Group R: 20 teeth/attachments with mesio-distal rotations - canines and premolars.
Digital study models (intraoral scanner) will be obtained before and after treatment. These intraoral scans will be analyzed alongside the planned movement models generated by the orthodontic treatment planning software.
Treatment efficacy will be analyzed using tooth-tracking methodology in Geomagic Control X, measuring the differences between planned and achieved movements and calculating the percentage of achieved orthodontic tooth movement.
Additionally, pre- and post-treatment clinical photographs will be taken:
Intraoral:
Frontal in occlusion; Right and left lateral views in occlusion; Occlusal views of upper and lower arches.
Extraoral:
Frontal with lips at rest; Frontal with a wide smile; Profile with lips at rest. All participants will receive orthodontic aligner treatment supervised by a qualified professional capable of providing relevant care under clinical trial conditions. Diagnosis, movement planning, and therapy monitoring procedures (e.g., aligner replacement frequency) for each individual will be established by the researcher, respecting the manufacturer's specified instructions.
The sample size was 30 participants will be recruited, totaling a sample of 120 teeth/attachments.
Participant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.
Initial and final digital models will be imported using software, where measurements will be taken to identify the magnitude and direction of movements resulting from treatment with different attachment types:
Horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Vertical displacements (extrusion and intrusion) - incisors. Mesio-distal rotations - canines and premolars.
Descriptive statistics will be calculated for each type of tooth movement evaluated and described by mean, standard deviation, median, quartiles, minimum, and maximum. Paired tests will be conducted due to the split-mouth design. Correlation tests will also be applied if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm: Beveled attachments | Experimental | Device: Arm 1: Beveled AttachmentsThe patients will receive beveled attachments on one side of the jaws |
| Rectangular Attachments | Active comparator | Device: Conventional Rectangular AttachmentsThe patients will receive rectangular attachments on one side of the jaws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18+ years) with permanent dentition
- Candidates for aligner-based orthodontic treatment
- Require bilateral tooth movements (e.g., extrusion, intrusion, rotation, tipping, mesiodistal translation)
- Provide written informed consent
Key exclusion criteria (3 listed)
- Contraindications to aligner use (e.g., manufacturer's guidelines)
- Poor oral hygiene, active periodontal disease, or TMJ disorders
- Allergies to aligner materials (e.g., polyurethane, PETG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm 1: Beveled AttachmentsBeveled attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements). | Device | Arm: Beveled attachments |
| Conventional Rectangular AttachmentsConventional rectangular attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements). | Device | Rectangular Attachments |
Primary outcome
To evaluate the efficacy of dental movement using beveled and conventional attachments
Time frame: From enrollment to the end of treatment, not exceeding 24 months.
Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.
3 secondary outcomes
To measure dental movements achieved with the treatment.
Time frame: From enrollment to the end of treatment, not exceeding 24 months.
Measure the transverse dental changes achieved.
Time frame: From enrollment to the end of treatment, not exceeding 24 months.
To assess participant satisfaction throughout the treatment.
Time frame: From enrollment to the end of treatment, not exceeding 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Beveled Attachments and Conventional Rectangular Attachments in people with Malocclusion and Tooth Movement Techniques, run by Neodent at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of dental movement using beveled and conventional attachments (time frame: From enrollment to the end of treatment, not exceeding 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.